Senior Director DMPK - Nonclinical Consulting
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Senior Director, with extensive expertise in Drug Metabolism and Pharmacokinetics (DMPK), to join our nonclinical consultancy team. As a Senior Director at ICON, you will work closely with other team members to provide expert scientific and strategic advice to our customers. This role is fully remote.
What you will be doing
* Providing expert knowledge of DMPK requirements on a variety of different projects, including small molecules and biopharmaceuticals, such as ADCs.
* Conducting in-depth review of nonclinical programmes to identify any gaps in the data package ahead of regulatory submission.
* Troubleshooting specific issues related to DMPK and strategising solutions
* Preparing written sections of regulatory submission documents pertaining to DMPK, including IBs and eCTD Modules.
* Identification of appropriate nonclinical CROs and placement / monitoring of DMPK studies on behalf of ICON’s customers.
* Engaging and driving business development initiatives.
Your profile
* Batchelor of Science (BSc) or above with minimum of 20 years experience in pharmaceutical development, including at least 10 years’ experience working as a DMPK subject matter expert (SME), with in depth knowledge of in vitro and in vivo assays, bioanalytical techniques and pharmacokinetic interpretation / modelling.
* Proven track record of decision making, planning and organising.
* A sound understanding of current regulatory guidelines and expectations for nonclinical ADME requirements across all phases of clinical development.
* Excellent communication and interpersonal skills, with the ability to represent the nonclinical team effectively both internally and externally.
* Self-motivated and confident to work independently with minimal supervision, but also an excellent team player. Ideally experience and a desire to take on a leadership role within the group.
* Some domestic and international travel is required from time to time, so a valid Driver's license and Passport is required.
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What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
* Various annual leave entitlements
* A range of health insurance offerings to suit you and your family’s needs.
* Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
* Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
* Life assurance
* Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply